It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.

The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine.
b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
The ZODIAC™ Polyaxial Pedicle Screw System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
In addition, the ZODIAC™ Polyaxial Pedicle Screw System, when used as a pedicle screw fixation system is intended for:
a. Patients receiving only autogenous bone graft.
b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
The ZODIAC™ Polyaxial Pedicle Screw System, when used as a laminar hook and bone screw system is intended for:
a. Patients having fractures of thoracic and lumbar spine.
b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

Device Description

Adjustable bridges function as transverse connectors. Transverse connectors are used in spinal constructs to add torsional rigidity. The devices come in a range of sizes to accommodate the patient's anatomy. The transverse connectors will be used as part of the ZODIAC Polyaxial Pedicle Screw System. Components are manufactured from titenium alloy, Ti-6AI-4V ELI (ASTM F 136) or stainless steel (ASTM F138).

AI/ML Overview

The provided text is a 510(k) summary for the ZODIAC™ Polyaxial Pedicle Screw System. It describes the device, its indications for use, and claims substantial equivalence to predicate devices based on mechanical and dynamic testing. However, it does not contain the detailed information necessary to fully answer all the requested points about acceptance criteria and a study proving those criteria are met, particularly regarding AI performance or human reader improvements.

Here's an analysis based on the available information:

ZODIAC™ Polyaxial Pedicle Screw System - Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary implies that the acceptance criteria for this device are implicitly tied to the performance of its predicate devices. The "performance" being evaluated is mechanical and dynamic.

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Devices)	Reported Device Performance
Mechanical Performance	Mechanical strength and integrity comparable to predicate devices.	"The test results demonstrate that the mechanical performance of the ZODIAC™ Polyaxial Pedicle Terrew System is at least comparable to, if not better than, those of the predicate devices."
Dynamic Performance	Dynamic stability and durability comparable to predicate devices.	"The test results demonstrate that the mechanical performance of the ZODIAC™ Polyaxial Pedicle Terrew System is at least comparable to, if not better than, those of the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

The document only states "Mechanical and dynamic testing of the transverse connectors as part of a spinal construct using the ZODIAC™ Polyaxial Pedicle Screw System was performed." It does not specify the sample size (e.g., number of constructs or individual components tested) nor the data provenance (e.g., country of origin, retrospective or prospective). This type of testing is typically conducted in a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The study described is a mechanical and dynamic performance test, not a study involving human interpretation or expert ground truth as typically understood in AI/medical imaging contexts. The ground truth for such a study would be the physical properties and failure points determined by engineering standards and measurements.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this was a mechanical test, not one requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The provided text describes a mechanical and dynamic performance study, not an MRMC study comparing human readers with and without AI assistance. Therefore, no effect size of human readers improving with AI vs. without AI assistance is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This device is a physical medical implant (pedicle screw system), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The ground truth for the mechanical and dynamic performance testing would be the quantitative data derived from the physical testing itself, measured against established engineering standards and specifications, and compared directly to the performance of the predicate devices. This is not "expert consensus, pathology, or outcomes data" in the typical clinical sense, but rather objective physical measurement data.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" for the mechanical testing described.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of device and study.

Summary

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K061321 (P9 | of 2) ZODIAC™ Polyaxial Pedicle Screw System 510(k) SUMMARY

July 5, 2006

Company: Alphatec Spine, Inc. 2051 Palomar Airport Road#100 Carlsbad, CA 92011 USA Telephone: (760) 431-9286 Fax: (760) 431-9132

JUL - 7 2006

Contact Person:	Paula Morgan, Director of Regulatory Affairs
Trade/Proprietary Name:	ZODIAC Polyaxial Pedicle Screw System
Common Name:	Pedicle Screw Spinal System
Classification Name:	Spinal Interlaminal Fixation Orthosis (888.3050)Spondylolisthesis Spinal Fixation Device (888.3070)Pedicle Screw Spinal System (888.3070)

Product Description:

Indications for Use:

l) The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
- Patients having fractures of the thoracic and lumbar spine. a.
- b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
- c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).

7.1

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ZODIAC™ Polyaxial Pedicle Screw System 510(k) SUMMARY July 5, 2006

1. The ZODIAC™ Polyaxial Pedicle Screw System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
1. In addition, the ZODIAC™ Polyaxial Pedicle Screw System, when used as a pedicle screw fixation system is intended for:
- a. Patients receiving only autogenous bone graft.
- b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
1. The ZODIAC™ Polyaxial Pedicle Screw System, when used as a laminar hook and bone screw system is intended for:
- a. Patients having fractures of thoracic and lumbar spine.
- b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
- c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).

Substantial Equivalence:

The ZODIAC™ Polyaxial Pedicle Screw System is substantially equivalent to the following predicate devices:

Trade/Proprietary Name	Manufacturer	Clearance
UCR Spinal System	SeaSpine	K043232
Moss-Miami Spinal System	Depuy Inc.	K982320
Universal Spine System	Synthes	K022949

Performance Data:

Mechanical and dynamic testing of the transverse connectors as part of a spinal construct using the ZODIAC™ Polyaxial Pedicle Screw System was performed. The test results demonstrate that the mechanical performance of the ZODIAC™ Polyaxial Pedicle Terrew System is at least comparable to, if not better than, those of the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2006

Alphatec Spine, Inc. % Paula Morgan Director of Regulatory Affairs 2051 Palomar Airport Road, Suite 100 Carlsbad, California 92011

Re: K061321

Trade/Device Name: ZODIAC Polyaxial Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH, KWP Dated: June 9, 2006 Received: June 13, 2006

Dear Ms. Morgan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buchup

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K061321

Device Name: ZODIAC Polyaxial Pedicle Screw System

Indications for Use:

1. The ZODIAC Polyaxial Pedicle Screw System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
- a. Patients having fractures of the thoracic and lumbar spine.
- b. Patients having deformity (i.e., idioscoliosis, neuromuscular scollosis, or kyphoscoliosis with associated paralysis or spasticity).
- c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis. degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
1. The ZODIAC Polvaxial Pedicle Screw System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
1. In addition, the ZODIAC Polyaxial Pedicle Screw System, when used as a pedicle screw fixation system is intended for:
- a. Patients receiving only autogenous bone graft.
- b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
1. The ZODIAC Polyaxial Pedicle Screw System, when used as a laminar hook and bone screw system is intended for:
- a. Patients having fractures of thoracic and lumbar spine.

b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity). (Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).
Prescription Use X (Per 21 CFR 801.109)

Over-The Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aarbera Buerem for mxm
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_K061321

Regulation Number and Section

N/A